General Information

Akten is a gel formulation of the local anesthetic agent lidocaine. Akten stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

Akten is specifically indicated as a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures.

Akten is supplied as an ophthalmic gel (3.5%) containing 35 mg per mL of lidocaine hydrochloride designed for topical ophthalmic administration. The recommended initial dose of the drug is two drops applied to the ocular surface in the area of the planned procedure. Akten may be reapplied to maintain anesthetic effect.

Clinical Results

FDA ApprovalFDA approval of Akten was based the results of a multi-center, randomized, controlled, double-blind study. This study enrolled 209 subjects who received placebo or Akten 1.5%, 2.5% or 3.5%. Ocular anesthesia was achieved within five minutes of anesthetic application by 47 of 51 subjects (92%) in the Akten 3.5% group. The mean time to anesthesia onset ranged from 20 seconds to 5 minutes and was not affected by Akten dose. The mean time to anesthesia onset was approximately 60 seconds, with a median onset time of 40 seconds for the Akten 3.5% group. Among the subjects in the Akten groups who achieved anesthesia within 5 minutes, approximately 90% had achieved anesthesia within 60 seconds of application. The duration of anesthesia generally ranged from approximately 5 minutes to 30 minutes, with mean anesthesia durations of approximately 15 minutes for the Akten 3.5% group. Approximately 84% of the subjects in the Akten 3.5% group experienced anesthesia for at least 5 minutes, approximately 55% of subjects experienced anesthesia for 10 minutes or longer and 27% experienced anesthesia for 15 minutes or longer.

Side Effects

Adverse events associated with the use of Akten may include, but are not limited to, the following:

Conjunctival hyperemia

Corneal epithelial changes

Headache

Burning upon instillation

Mechanism of Action

Akten is a gel formulation of the local anesthetic agent lidocaine. Akten stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. Anesthesia generally occurs between 20 seconds to 1 minute and persists for 5 to 30 minutes.

Additional Information

Akten Drug Information

The Akten drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.